STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.

K060253 · Regeneration Technologies, Inc. · HWC · Feb 23, 2006 · Orthopedic

Device Facts

• Record ID: K060253
• Device Name: STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.
• Applicant: Regeneration Technologies, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Feb 23, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The STERLING® Interference Screw ST is used to provide interference fixation of femoral and/or tibial tunnels in anterior cruciate ligament reconstruction using a soft tissue graft, and fixation during posterior cruciate ligament reconstruction utilizing a soft tissue graft. The STERLING® Interference Screw HT is used to provide interference fixation in anterior cruciate ligament reconstruction using a bone-tendon-bone graft, and fixation during posterior cruciate ligament reconstruction utilizing a bone-tendonbone graft.

Device Story

STERLING® Interference Screws are bone fixation fasteners used in orthopedic surgery for cruciate ligament reconstruction. Devices are machined from processed bovine cortical bone sourced from a closed herd in the U.S.A. STERLING® ST features an internal hexdrive; STERLING® HT features an external squared-drive. Both models are threaded with lengths of 20-35mm and diameters of 7-12mm. Used by orthopedic surgeons in clinical settings to provide interference fixation of grafts within femoral and tibial tunnels. The screws serve as mechanical anchors to secure grafts during the healing process. Benefit includes biocompatible fixation that remodels comparably to allograft.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing and an animal model study demonstrating that the device remodels comparably to allograft.

Technological Characteristics

Materials: Processed bovine cortical bone. Dimensions: 20-35mm length, 7-12mm diameter. Design: Threaded, with either internal hexdrive (ST) or external squared-drive (HT). Function: Interference fixation for ligament reconstruction.

Indications for Use

Indicated for patients undergoing anterior or posterior cruciate ligament reconstruction. STERLING® ST is indicated for use with soft tissue grafts; STERLING® HT is indicated for use with bone-tendon-bone grafts.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Submission Summary (Full Text)

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K060253

### 510(K) Summary

Date: February 22, 2006

Submitted by: Lisa Simpson Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615 Phone: [phone] x4326 Fax: [phone]

Proprietary Name: STERLING® Interference Screw HT STERLING® Interference Screw ST

Common Name: Screw, fixation, bone

Classification: HWC, orthopedics panel

Code Section: 21 CFR 888.3040

#### Substantial Equivalence:

The STERLING® Interference Screw HT and STERLING® Interference Screw ST are substantially equivalent to predicate devices in materials, design, and function.

#### Description:

The STERLING® Interference Screw HT is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw HT is threaded and has an external squared-drive.

The STERLING® Interference Screw ST is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw ST is threaded and has an internal hexdrive.

#### Intended Use:

The STERLING® Interference Screw ST is used to provide interference fixation of femoral and/or tibial tunnels in anterior cruciate ligament reconstruction using a soft tissue graft, and fixation during posterior cruciate ligament reconstruction utilizing a soft tissue graft.

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K066253 page-sq2

The STERLING® Interference Screw HT is used to provide interference fixation in The STERENTS Interent reconstruction using a bone-tendon-bone graft, and fixation during posterior cruciate ligament reconstruction utilizing a bone-tendonbone graft.

## Summary of Technological Characteristics:

Summally of Technological Characew HT and the STERLING® Interference Screw ST have materials, design and function equivalent to predicate devices. The source S f have materials, accession and sufference of STERLING® Interference Screw HT and STERLING® Interference Screw ST is a closed herd located in the U.S.A. The STERLING® Interference Screw HT and STERLING® Interference Screw ST have been shown to remodel comparably to allograft in an animal model.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2006

Ms. Lisa Simpson Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615

Re: K060253

Trade/Device Name: Sterling® Interference Screw HT, Sterling® Interference Screw ST Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 1, 2006 Received: February 1, 2006

Dear Ms. Simpson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Lisa Simpson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Herbert Lewis

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: STERLING® Interference Screw HT STERLING® Interference Screw ST

Indications for Use:

The STERLING® Interference Screw ST is used to provide interference fixation of f moral and/or tibial tunnels in anterior cruciate ligament reconstruction using a soft tissue graft, and fixation during posterior cruciate ligament reconstruction utilizing a soft tissue graft.

The STERLING® Interference Screw HT is used to provide interference fixation in anterior cruciate ligament reconstruction using a bone-tendon-bone graft, and fixation during posterior cruciate ligament reconstruction utilizing a bone-tendonbone graft.

Over-The-Counter Use No Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Herlin Lewin

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________